Bioequivalence Study of Two Formulations of Bisoprolol Fumarate Tablets in Healthy Subjects

The aim of this study was to evaluate the bioequivalence of Diopolol (containing Bisoprolol fumarate 10 mg) tablet of SAVA Healthcare Ltd, India with Concore (Containing Bisoprolol hemifumarate 10 mg) tablet of Merck Serono, Germany in healthy adult volunteers. This open label, balanced, single-dose, randomized, two period, two sequences ,crossover oral bioequivalence study was conducted in 24 healthy human adult male subjects under fasting condition. Subjects received bisoprolol 10 mg of either test or reference formulation with a washout period of 7 days. After study drug administration, serial blood samples were collected over a period of 48 hours. The plasma concentrations of bisoprolol were determined by a validated method using LC/MS/MS. Pharmacokinetic parameters Cmax, Tmax, T1/2, AUC0-t, AUC0-∞, and kel, were determined for both the formulations. The formulations were to be considered bioequivalent if the geometric least square mean ratio of test and reference of Cmax, AUC0-t, and AUC0-∞, were within the predetermined bioequivalence range of 80% to 125%. A total of 24 subjects were enrolled. No significant differences were found based on analysis of variance. The 90% confidence intervals (CI) of Cmax, AUC0-t and AUC0-∞, of bisoprolol were 103.29 - 115.15, 103.73 - 116.62, and 94.78 - 116.64 respectively This study shows that the test formulation is bioequivalent to the reference formulation for bisoprolol.